"On December 16, 2014, the U. S. Food and Drug Administration approved lanreotide (Somatuline Depot Injection, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroe"...
Xgeva Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: jaw pain, new or unusual thigh/hip/groin pain, shortness of breath.
Denosumab may cause very serious (rarely fatal) low levels of calcium in the blood, especially if you have kidney problems. Take calcium and vitamin D as directed by your doctor. (See also How to Use section.) Get medical help right away if you have any symptoms of low calcium such as: severe muscle spasms/cramps, mental/mood changes (such as irritability or confusion), numbness/tingling (especially around lips/mouth or in fingers/toes), seizures, severe dizziness/fainting.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Xgeva (denosumab) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using denosumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: low level of calcium in the blood (hypocalcemia), kidney disease.
Infrequently, people using this medication have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. Be sure to brush and floss your teeth daily and get regular dental exams/cleaning. If you develop jaw pain, tell your doctor and dentist right away.
Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products).
Denosumab is not recommended for use in children except for the treatment of giant cell tumor of the bone (see also Uses section). It may slow down a child's growth and affect tooth development.
This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication and for at least 5 months after treatment. Therefore, females must use reliable forms of birth control during treatment and for at least 5 months after treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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